Registration Dossier

Ecotoxicological information

Long-term toxicity to fish

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Administrative data

Link to relevant study record(s)

fish early-life stage toxicity
Data waiving:
other justification
Justification for data waiving:
Reason / purpose:
data waiving: supporting information
Reason / purpose:
data waiving: supporting information

Description of key information

Data waiving in accordance with column 2 of REACH Annex IX.

Key value for chemical safety assessment

Additional information

In accordance with column 2 of REACH Annex IX, long-term toxicity testing on fish shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on fish. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Regulation (EC) No 1272/2008 (CLP) or is assessed to be a PBT or vPvB. The hazard assessment of butane-1,3-diol reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. Therefore and for reasons of animal welfare, a long-term toxicity test in fish is not proposed.